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Millipore and Gen-Probe Launch First Real-Time Test for Detecting Microbial Contamination in Biopharmaceutical Applications

Industry leaders create innovative MilliPROBETM system to quickly identify contaminants and ensure drug purity for biopharmaceutical manufacturers.
Millipore Corporation and Gen-Probe have announced the launch of the first product from their ground-breaking collaboration to create faster, sensitive, more robust tests for detecting contaminants in pharmaceutical and biotechnology manufacturing processes. The MilliPROBE system is the first solution of its kind for biopharmaceutical manufacturing. It combines Millipore's leading, industry-accepted sample prep methodologies with Gen-Probe's advanced, proven nucleic acid technologies to deliver both speed and sensitivity in one microbial screening tool.

The MilliPROBE system uses Real-Time Transcription-Mediated Amplification (TMA) technology to detect targeted microbial contamination within hours compared to the days or weeks usually required to generate results using traditional culture-based technology. Faster detection allows biopharmaceutical manufacturers to take corrective action earlier in the production process, which reduces downstream processing risks, optimizes product yields, and improves final product quality. These improvements may result in better operational efficiency and lower manufacturing cost for product manufacturers.

"The launch of our first MilliPROBE product represents a significant scientific breakthrough and demonstrates the promise new technologies offer for quick and accurate detection of microbial contaminants in biopharmaceutical processes," said Martin Madaus, Chairman & CEO of Millipore. "For the first time, Millipore's biotechnology and pharmaceutical customers have a viable alternative to culture-based tests that can take several days to generate results. We are excited about the progress we have made in our collaboration with Gen-Probe and we look forward to developing additional assays using the MilliPROBE system over the next few years."

The collaboration's first MilliPROBE assay targets the bacterium Pseudomonas aeruginosa and is designed as an in-process, early warning system to provide faster, more effective detection of Pseudomonas aeruginosa in purified water used during drug production. The assay was designed to ensure a higher degree of water quality throughout manufacturing processes where the contaminant can be a serious quality and safety concern. The components of the MilliPROBE system are developed, manufactured and tested to work together to provide customers a complete solution that generates consistent, dependable results.

"We are pleased with the initial results of this collaborative effort between Millipore and Gen-Probe," said Hank Nordhoff, Chairman, President and CEO of Gen-Probe. "Scientists from both companies are breaking new ground in combining best-in-class technologies to meet the needs of pharmaceutical and biopharmaceutical manufacturers. We believe there is a bright future for this new generation of rapid, real-time TMA-based screening tools."

Building on the technological innovation of the initial MilliPROBE assay, Millipore and Gen-Probe intend to continue to develop new assays for additional contaminants over the next few years. These assays are expected to provide further significant improvements in speed, sensitivity, and specificity and incorporate future sample prep innovations that will allow real-time TMA technology to be applied to more challenging biopharmaceutical applications and target microorganisms.